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2964 GI/2017 (1) REGD. NO. D. L.-33004/99 EXTRAORDINARY II(i) PART IISection 3Sub-section (i) PUBLISHED BY AUTHORITY 349] No. 349] NEW DELHI, FRIDAY, MAY 5, 2017/VAISAKHA 15, 1939 वाय र रिवा लया त् रालय (वाय र रिवा लया भवगा अभिसूचना नई दिली, 5 तई, 2017 सा.ला.भन. 441(अ.नैिाभनल थारन (लेरीय सला भनयत, 2012 ला र स्शोिन लने ले भलए लभिरय भनयत ला भननभलभति ार, भिह लेरीय सला ला नैिाभनल थारन (भिरील र भवभनयतन अभिभनयत, 2010 (2010 ला 23 ली िाा 52 ाा िि ली ई शभिय ला यो लिे ए, नैिाभनल थारन ले भलए ारीय रिषि् से रातशश लने ले रचाि्, बनाने ला िाव है , उन सगी यभिय ली िानलाीलेभलए, भिनले उससे गाभवि होने ली स्गावना है , लाभशि दलया िािा है र इसले ाा यह सूचना िी िािी है दल उि ार भनयत र उस िाीसे , भिसलो इन ार भनयत वाले गाि ले ािरर ली भिया् िनिा लो उरलि ला िी िािी हं , रंिालीस दिन ली अवभि ली सताभि र या उसले रचाि् , भवचा दलया िाएा । ऐसे आेर र सुझाव, यदि लोई ह, अव सभचव (भचदलसा सेवा, वाय र रिवा लया त्रालय, गाि सला, लता स्. 508, डी वव्, भनताश गवन, नई दिली-110011 लो गेिे िा सलिे हं या [email protected] र तेल दलए िा सलिे हं । ऐसे आेर र सुझाव , िऊर भवभनिशट अवभि ले गीि दलसी यभि से ाि ह, लेरीय सला ाा भवचा दलया िाएा । ार भनयत 1. (1 इन भनयत ला स्भि नात नैिाभनल थारन (लेरीय सला स्शोिन भनयत, 2017 है । (2 ये ािरर त उनले अ्भित लाशन ली िाीत लो वृि हे ।
16

स्वास््यर रि वा ल्याण म ...2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] न भनल स थ रन (ल न द रय स ल

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Page 1: स्वास््यर रि वा ल्याण म ...2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] न भनल स थ रन (ल न द रय स ल

2964 GI/2017 (1)

REGD. NO. D. L.-33004/99

EXTRAORDINARY

II— — (i)

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

349]

No. 349] NEW DELHI, FRIDAY, MAY 5, 2017/VAISAKHA 15, 1939

स‍वास‍ ‍य‍र ‍रि वा ‍ल‍‍याण म‍तरालय

(स‍वास‍ ‍य‍र ‍रि वा ‍ल‍‍याण म‍भवगा ‍

अभिसचना

नई‍दि‍‍ली, 5‍तई,‍2017

सा.ला.भन. 441(अ .—निाभनल‍स‍थारन‍ (लन‍द‍रीय‍स ला ‍ भनयत,‍2012‍ला‍र ‍ सशोिन‍ल न‍ ल‍ भलए‍लभिरय‍

भनयतो‍ ला‍ भनम‍नभलभति‍ ार,‍ भिन‍द‍ह‍ लन‍द‍रीय‍ स ला ‍ ला‍ निाभनल‍ स‍थारन‍ ( भिस‍रील ण म‍र ‍ भवभनयतन ‍ अभिभनयत,‍

2010‍ (2010‍ला‍23 ‍ली‍िा ा‍52‍दवा ा‍ित‍ि‍ली‍ ई‍शभियो‍ला‍यो ‍ल ि‍हए,‍निाभनल‍स‍थारनो‍ ल‍ भलए‍ ा‍‍रीय‍

रि षि‍स‍र ातशश‍ल न‍ल‍रश‍चाि,‍बनान‍ला‍स‍िाव‍ह,‍उन‍सगी‍व‍यभियो‍ली‍िानला ी‍ल‍भलए,‍भिनल‍उसस‍गाभवि‍

होन‍ली‍सगावना‍ह,‍लाभशि‍दलया‍िािा‍ह‍र ‍इसल‍दवा ा‍यह‍सचना‍िी‍िािी‍ह‍दल‍उक‍ि‍ार‍भनयतो‍र ‍उस‍िा ीत‍

स,‍ भिसलो‍इन‍ार‍ भनयतो‍वाल‍गा ि‍ ल‍ ािरर‍ली‍भिया‍िनिा‍लो‍उरलब‍ि‍ल ा‍िी‍िािी‍ह,‍रिालीस‍ दिन‍ली‍

अवभि‍ली‍सताभि‍र ‍या‍उसल‍रश‍चाि,‍भवचा ‍दलया‍िाए ा‍।

ऐस‍आकषर‍र ‍सझाव,‍यदि‍लोई‍हो,‍अव ‍सभचव‍(भचदलत‍सा‍सवा ,‍स‍वास‍ ‍य‍र ‍रि वा ‍ल‍‍याण म‍तरालय,‍गा ि‍

स ला ,‍लत ा‍स.‍508,‍डी‍वव ,‍भनताशण म‍गवन,‍नई‍दि‍‍ली-110011‍लो‍गि‍िा‍सलि‍ह‍या‍[email protected]

र ‍त‍ल‍दलए‍िा‍सलि‍ह‍।‍

ऐस‍आकषरो‍र ‍सझावो‍र ,‍िो‍ऊर ‍भवभनरिश‍‍ट‍अवभि‍ल‍गीि ‍दलसी‍व‍यभि‍स‍ा‍‍ि‍हो,‍लन‍द‍रीय‍स ला ‍दवा ा‍

भवचा ‍दलया‍िाए ा‍।‍

ार‍भनयत

1.‍(1 ‍इन‍भनयतो‍ला‍सभकष‍‍ि‍नात‍निाभनल‍स‍थारन‍(लन‍द‍रीय‍स ला ‍सशोिन‍भनयत,‍2017‍ह‍।‍

(2 ‍य‍ ािरर‍त‍उनल‍अभित‍लाशन‍ली‍िा ीत‍लो‍वत‍ि‍हो ‍।‍

Page 2: स्वास््यर रि वा ल्याण म ...2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] न भनल स थ रन (ल न द रय स ल

2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

2.‍निाभनल‍स‍थारन‍(लन‍द‍रीय‍स ला ‍भनयत‍ल,‍2012‍(भिस‍इसत‍इसल‍रश‍चाि‍उक‍ि‍भनयत‍लहा‍ या‍ह ‍भनयत‍2‍त,‍तड‍

(त ‍ल‍रश‍चाि‍भनम‍नभलभति‍तड‍अन‍द‍ि:स‍थाभरि‍दलया‍िाए ा,‍अथाशि.-

‘(त‍त “अनसची”‍स‍इन‍भनयतो‍स‍सलग‍न‍अनसची‍अभगि‍ह‍।’

3.‍उक‍ि‍भनयतो‍त,‍भनयत‍8‍ल‍रश‍चाि‍भनम‍नभलभति‍भनयत‍अन‍द‍ि:‍स‍थाभरि‍दलए‍िाए ,‍अथाशि‍:-‍

‘‘8ल.‍भनिान‍या‍ ो ो‍ल‍उरचा ‍ल‍भलए‍न‍द‍यनित‍तानल.—भनिान‍या‍ ो ो‍ल‍उरचा ‍स‍सबभिि‍त‍यल‍निाभनल‍

स‍थारन,‍ िहा‍ यो शाला‍ या‍ अन‍द‍य‍ भचदलत‍सीय‍ उरस‍ल ‍ ली‍ सहायिा‍ स‍ भवलभि‍ भवजञान,‍ िीवाण म‍ भवजञान,‍ आनवभशली,‍

भवदल ण म‍ भवजञान,‍ ासायभनल,‍ िभवल‍ अन‍द‍वषण म‍ या‍ अन‍द‍य‍ निाभनल‍ या‍ िाच-रडिाल‍ सबिी‍ सवाए‍ ाय:‍ ली‍ िािी‍ ह,‍ व‍

अनसची‍त‍यथाभवभनरिश‍‍ट‍सभविा ‍र ‍सवा ‍ल‍न‍द‍यनित‍तानलो‍ला‍अनरालन‍ल ‍।’’‍

4.‍उक‍ि‍भनयतो‍त,‍भनयत‍9‍ल‍रश‍चाि‍भनम‍नभलभति‍अनसची‍अन‍द‍ि:‍स‍थाभरि‍ली‍िाए ी,‍अथाशि:-‍‍‍

‘‘अनसची

करत‍स.‍ यो शाला‍ला‍ला बभनयािी‍भवभवि तध‍यत‍यो शाला‍ उन‍द‍नि‍यो शाला‍

I रि गाषा यो शालाए‍ िो‍ 30‍

नतनो‍ ला‍ सस‍ल ण म‍

ल िी‍ह‍

यो शालाए‍ िो‍ 30‍ स‍

100‍ नतनो‍ ला‍

सस‍ल ण म‍ल िी‍ह‍

यो शालाए‍िो‍100‍स‍अभिल‍

नतनो‍ला‍सस‍ल ण म‍ल िी‍ह‍

II सवा ‍ला‍भवस‍िा य‍र ीकषण म‍लायशकषर‍लन‍द‍रो‍

र ‍ चलिी-दि िी‍

यो शाला‍ त‍ गी‍ दलए‍

िा‍सलि‍ह‍

इन‍ र ीकषण मो‍ ल‍ अलावा‍

बभनयािी‍ भवभवि‍

यो शाला‍ त‍ नीच‍

उभ‍लभति‍र ीकषण म‍ दलए‍

िा‍सलि‍ह‍

तध‍यत‍ यो शाला ‍ त‍ दलए‍

िा‍ ह‍ र ीकषण मो‍ ल‍ अभिि क‍ि,‍

नीच‍ उभ‍लभति‍ अभिि क‍ि‍

र ीकषण म‍दलए‍िा‍सलि‍ह‍

(ल ‍िीव‍ सायन नती‍िीव‍ सायन‍

र ीकषण म‍िस‍ब‍लड‍श ,‍

ि नल‍िक‍शन‍र ीकषण म,‍

भलव ‍िक‍शन‍टस‍ट,‍

अतीलस,‍भलरास‍भलभरड‍

ोिाइल,‍स ीबरो‍

स‍राइनल‍फलड‍

(सीएसएि ‍र ‍अन‍द‍य‍

िभवल‍फलडस,‍(ग‍ललोस‍

र ‍ोटीन,‍ओ ल‍

ग‍ललोस‍टाल स‍टस‍ट,‍

इलक‍रोलाइटस,‍

लभ‍शयत‍या‍िास‍िट,‍

एचबीए‍1सी‍र ‍लोई‍

श‍‍ल‍ ासायन‍आिाि ि‍

भरड‍टस‍ट‍‍

(ल ‍नती‍िीव- सायन,‍

(त ‍हा तोन‍बायोएस‍स,‍

टयत ‍तालशसश,‍‍‍लािता‍

ोटीन‍इ‍‍लरोिी भसस

(ल ‍नती‍िीव- सायन,‍

(त ‍ हा तोन‍बायोएस‍स,‍टयत ‍

तालशसश,‍ ‍‍लािता‍ ोटीन‍

इ‍‍लरोिो भसस,‍ लोया लशन‍

ोिाइल,‍ डर ‍ तानीटर ‍ र ‍

भवषभवजञान‍एस‍स

( ‍अण म‍आनवभशली‍ स‍दकरया‍

ली‍नसर शल‍रिट

(त ‍भि ‍भवजञान‍ हतोगरात,‍ब‍लीवड ‍टाइत,‍

क‍लोरट ‍टाइत,‍

ोथरोतभबन‍टाइत,‍

एलटीबटड‍रा भसयल‍

हतोगरात,‍ब‍लीवड ‍

टाइत,‍क‍लोरट ‍टाइत,‍

ोथरोतभबन‍टाइत,‍

एलटीबटड‍रा भसयल‍

सगी‍अन‍द‍य‍भि ‍भवजञान‍सबिी‍

र ीकषण म‍गी‍

Page 3: स्वास््यर रि वा ल्याण म ...2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] न भनल स थ रन (ल न द रय स ल

II (i) 3

थरोबो‍‍लाभसटन‍टाइत,‍

ब‍लड‍गरवर ‍

थरोबो‍‍लाभसटन‍टाइत,‍

ब‍लड‍गरवर ,‍लो लशन‍

एस‍स

( ‍ऊिल‍भवलभि‍

भवजञान‍

ला ‍नही‍होिा हो‍सलिा‍ह‍या‍नही‍ल ‍

सलि‍ह‍(वलभ‍रल ‍

ऊिल-भवलभि‍भवजञान‍र ीकषण म‍

(घ ‍अण म‍आनवभशली ला ‍नही‍होिा हो‍सलिा‍ह‍या‍नही‍ल ‍

(वलभ‍रल ‍‍

अण म‍आनवभशली

(ङ ‍लोभशला‍भवलभि‍

भवजञान‍

ला ‍नही‍होिा रीएरी‍स‍तीअ ,‍िाइन‍

नीडल‍एसभर शन‍

बल त‍(एिएनएसी ‍‍

र ‍सीएसए‍ि‍लोभशला‍

भवजञान‍

रीएरी‍स‍तीअ ,‍एिएनएसी‍

र ‍बल त‍(साईटोलोिी ‍‍

लोभशला‍भवलभि‍भवजञान‍र ‍

अन‍द‍य‍

वाछनीय:

अ‍‍रासाउड‍र ‍सीटी‍

ता शिरशशि‍एिएनएसी

(च ‍भि कषा‍ऊिल‍

भवलभि‍भवजञान‍

ला ‍नही‍होिा ला ‍नही‍होिा भि कषा‍ऊिल‍भवलभि‍भवजञान‍

यो शाला‍ल‍भवस‍िा ‍ल‍

अनसा ‍‍

(छ ‍भचदलत‍सा‍

सकष‍तिीव‍भवजञान‍र ‍

भि कषा‍भवजञान‍

बभनयािी‍र ीकषण म‍िस‍

भरड‍टस‍ट‍(‍‍वाइट‍आि‍

लय ‍सकरतण म‍ल‍भलए‍

र ीकषण म,‍तर‍टीन‍

र ीकषण म‍ताइकरोस‍लोरी,‍

हव ‍डरार‍िा ‍भववि यो‍

लोल ,‍स‍टल‍िा ‍ओवा,‍

सौली।‍सगी‍एचआईवी‍

रॉभििटव‍ भरड‍एस‍स‍

भिसली‍रभि‍अ ल‍स‍ि ‍

ली‍निाभनल‍यो शाला‍

स‍ली‍िाए ी‍

(ल ‍बभनयािी‍भवभवि‍

यो शाला‍त‍ल‍

बभनयािी‍र ीकषण म

(त ‍भवषाण म,‍िीवाण म,‍

ििि,‍र िीवी‍सबिी‍

सी त‍भवजञान‍र ीकषण म

( ‍लषशण म‍सविनशीलिा‍

र ीकषण म,‍िीवाण म‍या‍

ििि

(घ ‍गरातस‍ल‍अलावा‍

अन‍द‍य‍भवशष‍िब‍ब

(ल ‍बभनयािी‍भवभवि‍

यो शाला‍त‍ल‍बभनयािी‍

र ीकषण म

(त ‍भवषाण म,‍िीवाण म,‍ििि,‍

र िीवी‍सबिी‍सी त‍भवजञान‍

र ीकषण म

( ‍लषशण म‍सविनशीलिा‍

र ीकषण म,‍िीवाण म‍ििि‍या‍

भवषाण म।‍

(घ ‍िीन‍आिाि ि‍र ीकषण म‍

(न‍द‍यदलभलल‍एभसड‍र ीकषण म‍

सकरतण म‍िस‍ि यल‍टाइत‍

रॉलीत स‍चन‍ि एक‍शन‍‍

(रीसीआ ‍र ीकषण म‍ल‍भलए,‍

सकरभति‍ ो ो‍ल‍भलए‍ऊिल‍

भवलभि‍भवजञान‍र ीकषण म।‍

वाछनीय:

इम‍यनोसाइटोच‍भतस‍री

III अवस चना

बभनयािी‍भवभवि‍ तध‍यत‍ उन‍द‍नि

1.‍सालभिल‍भचहन

बभनयािी‍साइनि-

सभविा‍ल‍गीि ‍या‍

बाह ‍एल‍साइनि‍

उरलब‍ि‍हो ा‍भिसत‍

भनम‍नभलभति‍िानला ी‍

हो ी

आवश‍यल‍ आवश‍यल‍ आवश‍यल

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4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

(ल ‍अहशिा‍र ‍

भिस‍रील ण म‍सा‍याल‍

ल‍साथ‍गा सािल‍

व‍यभि‍ला‍नात

आवश‍यल‍ आवश‍यल‍ आवश‍यल

(त ‍िी‍िान‍वाली‍

व‍यारल‍सवाए‍अथाशि‍

भि ‍भवजञान,‍िव‍

सायन,‍निाभनल‍

भवलभि‍भवजञान,‍ऊिल‍

भवजञान,‍अण म‍

आनवभशली‍िो‍लोई‍

गी‍ला ‍हो

आवश‍यल‍ आवश‍यल‍ आवश‍यल

( ‍भवभगन‍द‍न‍

र ातशशिािा ‍ली‍

सतय‍सा ण मी

आवश‍यल‍ आवश‍यल‍ आवश‍यल

(घ ‍भतलन‍ला‍सतय‍

भनयि‍ल न‍ल‍भलए‍

इन‍द‍ट नट‍सभविा‍या‍

टलीिोन‍र ‍तोबाइल‍

न.‍

वाछनीय वाछनीय वाछनीय

(ङ ‍िीस‍स चना:‍

अल ‍स‍िरशशि‍ली‍

िाए ी‍र ‍इसल‍

अन‍द‍ि शि‍अन‍द‍वषण म‍र ‍

गा ‍गी‍ह‍अथाशि‍

भवशष‍या‍नती‍र ीकषण म

आवश‍यल आवश‍यल आवश‍यल

2.‍सालभिल‍भचहन‍(िहा‍लही‍ला ‍हो

(ल ‍स कषा‍ति ा‍र ‍

चिावनी‍भचहन-

िवभचदलत‍सा‍अरभश‍‍ट‍

बिन‍भनयत,‍2016‍

ल‍अनसा ‍

िवभचदलत‍सा‍अरभश‍‍‍ट‍

लो‍ ीन‍भडब‍बो‍त‍

अल -अल ‍ल ना,‍

भिसल‍अन‍द‍ि शि‍

भवदल ण म‍सातगरी,‍

भवषल‍ सायन,‍

ताइकरोबाइल‍एिन‍द‍टस,‍

सकरभति‍िभवलीय‍

सातगरी‍गी‍ह‍।‍‍‍‍‍

आवश‍यल‍ आवश‍यल आवश‍यल

(त ‍सतभचि‍अभि‍

भनलास‍सालभिल‍

भचहन-न‍द‍यनित‍एल‍

अभिशातल‍

वाछनीय वाछनीय‍ आवश‍यल

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II (i) 5

3.‍स‍थान‍अरकषा‍

(ल ‍ भिस‍रील ण म‍र ‍

िीकषा‍लकष,‍

िनउरयो ी‍सभविाए,‍

स भकषि‍रीन‍ला‍रानी‍

आदि

वाछनीय‍ आवश‍यल‍ आवश‍यल

(त ‍नतना‍सगरहण म‍कषर‍ आवश‍यल आवश‍यल आवश‍यल

( ‍रयाश‍‍ि‍भडफयस‍

र ‍स‍राट‍लाइरट ‍ल‍

साथ‍यो शाला

आवश‍यल आवश‍यल आवश‍यल

(घ ‍शौचालय आवश‍यल आवश‍यल आवश‍यल

(ङ ‍ि रोटश‍िन‍र ‍

भबवल ‍कषर‍‍

आवश‍यल आवश‍यल आवश‍यल

(च ‍स‍टाि‍त‍र ‍

डाक‍ट ‍ला‍टी‍त-‍

िहा‍24‍घट‍ली‍सवाए‍

उरलब‍ि‍ह‍वहा‍रष‍

र ‍तभहला ‍ल‍लकष‍

अल -अल ‍हो

वाछनीय‍ वाछनीय‍ आवश‍यल‍

(छ ‍वावश ‍त‍ आवश‍यल आवश‍यल आवश‍यल

(ि ‍नतनो‍र ‍

स‍लाइडो‍ला‍रि कषण म

आवश‍यल आवश‍यल आवश‍यल

(झ ‍भवदयि‍सभविाए‍ आवश‍यल आवश‍यल आवश‍यल

(ञ ‍भवशष‍उरस‍ल ‍

िस‍फलो‍साइटोतीट ी‍

र ‍चतइ‍‍यभतनीसन‍द‍स‍

उरस‍ल ,‍एिाइत-

वलक‍ड‍इतयनसो बट‍

एस‍स‍‍(ईएलआईएसए ‍

र ीकषण म‍उरस‍ल ‍आदि‍

ल‍भलए‍िारतान‍

भनयरल

आवश‍यल आवश‍यल आवश‍यल

(ट ‍एचआईवी‍ल‍भलए‍

र ातशश‍लकष‍‍

आवश‍यल‍यदि‍एचआईवी‍

र ीकषण म‍दलया‍ या‍ह‍

आवश‍यल‍यदि‍

एचआईवी‍र ीकषण म‍

दलया‍ या‍ह

आवश‍यल‍यदि‍एचआईवी‍

र ीकषण म‍दलया‍ या‍ह

(ठ ‍सगी‍ ोभ यो‍ल‍

नतनो‍ल‍सगरहण म‍ल‍

भलए‍एिएनएसी‍लकष

वाछनीय वाछनीय वाछनीय

(ड ‍इतनोफलो सस‍ल‍

भलए‍डालश ‍त‍

ला ‍नही‍होिा ला ‍नही‍होिा‍ आवश‍यल

(ढ ‍फरोिन‍सक‍शन‍

सभविाए‍

ला ‍नही‍होिा‍ सवा ‍ल‍भवस‍िा ‍ल‍

अनसा ‍आवश‍यल

सवा ‍ल‍भवस‍िा ‍ल‍अनसा ‍

आवश‍यल

4.‍िनीच ‍र ‍

दिक‍सच ‍

आवश‍यल‍ आवश‍यल आवश‍यल

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6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

5.‍ससचना‍िर-सतय‍

भनयि‍ल न‍ल‍भलए‍

टलीिोन‍र ‍तोबाइल‍

न.‍‍

वाछनीय वाछनीय वाछनीय

6.‍वाश‍बभसन आवश‍यल आवश‍यल आवश‍यल

IV तानव‍ससािन

रिनात,‍यो शाला‍ल‍

िलनीली‍गा सािल‍

या‍भवशषजञ‍या‍

हस‍िाकष लिाश‍ली‍

न‍द‍यनित‍अहशिा

आवश‍यल:‍दलसी‍

तान‍द‍यिाा‍‍ि‍सस‍था‍स‍

बचल ‍आि‍तभडभसन‍

एड‍बचल ‍आि‍सिश ी‍

(एतबीबीएस ‍

(यो शाला‍लायश‍त‍लत‍

स‍लत‍एल‍वषश‍ला‍

अनगव-‍वाछनीय ‍

आवश‍यल:‍गा सािल‍

भवलभि‍भवजञान‍या‍

िव सायन‍या‍

भचदलत‍सीय‍सकष‍तिभवली‍

या‍यो शाला‍ओषभि‍

त‍डाक‍ट ‍आि‍तभडभसन‍

(एतडी ‍या‍भड‍‍लोतट‍

आि‍नशनल‍बोडश‍

(डीएनबी ‍या‍निाभनल‍

भवलभि‍भवजञान‍त‍

भड‍‍लोता‍‍(डीसीरी ‍

र ‍भड‍‍लोता‍ल‍रश‍चाि‍

एल‍वषश‍ला‍अनगव‍या‍

बचल ‍आि‍तभडभसन‍

एड‍बचल ‍आि‍सिश ी‍‍

(एतबीबीएस ‍ल‍साथ‍

िीन‍भवषयो‍त‍स‍एल‍

भवषय‍त‍डाक‍ट ‍आि‍

िलॉसिी‍(रीएचडी ,‍

गा सािल‍हो‍सलिा‍ह‍

या‍इसल‍‍अभिि क‍ि‍

यदि‍अन‍द‍य‍भवशषजञिा‍ला‍

लोई‍अन‍द‍य‍भवशष‍

र ीकषण म‍दलया‍िािा‍ह‍

िब‍यह‍वाछनीय‍ह‍दल‍

उस‍भवषय‍ल‍भवशषजञ‍

लो‍रण मशलाभलल‍या‍

अशलाभलल‍र‍स‍वहा‍

हन‍ली‍आवश‍यलिा‍‍ह‍

या‍(भवशष‍र ीकषण म‍स‍

अभगि‍ह‍नती‍

बभनयािी‍िव सायन,‍

भि ‍भवजञान‍या‍

भचदलत‍सा‍सकष‍तिभवली‍

ल‍अभिि क‍ि‍लोई‍ऐसा‍

र ीकषण म‍भिस‍बभनयािी‍

भवभवि‍यो शाला‍त‍

सचीबदध‍दलया‍ या‍ह ‍‍‍‍

आवश‍यल:‍गा सािल‍भवलभि‍

भवजञान‍या‍यो शाला‍ओषभि‍

िव सायन‍त‍डाक‍ट ‍आि‍

तभडभसन‍(एतडी ‍या‍भड‍‍लोतट‍

आि‍नशनल‍बोडश‍(डीएनबी ‍या‍

निाभनल‍भवलभि‍भवजञान‍त‍

भड‍‍लोता‍‍(डीसीरी ‍र ‍

भड‍‍लोता‍ल‍रश‍चाि‍एल‍वषश‍ला‍

अनगव‍या‍बचल ‍आि‍

तभडभसन‍एड‍बचल ‍आि‍

सिश ी‍(एतबीबीएस ‍ल‍साथ‍

िीन‍भवषयो‍त‍स‍एल‍भवषय‍त‍

डाक‍ट ‍आि‍िलॉसिी‍

(रीएचडी ,‍गा सािल‍हो‍

सलिा‍ह‍या‍इसल‍‍अभिि क‍ि‍

यदि‍अन‍द‍य‍भवशषजञिा‍ला‍लोई‍

अन‍द‍य‍भवशष‍र ीकषण म‍दलया‍

िािा‍ह‍िब‍यह‍वाछनीय‍ह‍दल‍

उस‍भवषय‍ल‍भवशषजञ‍लो‍

रण मशलाभलल‍या‍अशलाभलल‍र‍

स‍वहा‍ हन‍ली‍आवश‍यलिा‍ह‍

या‍(भवशष‍र ीकषण म‍स‍अभगि‍

ह‍नती‍बभनयािी‍िव सायन,‍

भि ‍भवजञान‍या‍भचदलत‍सा‍

सकष‍तिभवली‍ल‍अभिि क‍ि‍लोई‍

ऐसा‍र ीकषण म‍भिस‍ऊर ‍

सचीबदध‍दलया‍ या‍ह

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II (i) 7

भवश‍वभवदयालय‍या‍

तान‍द‍यिाा‍‍ि‍सस‍था‍स‍

यो शाला‍भवजञान‍त‍

भड‍‍लोता‍इन‍तभडलल‍

लबोर ी‍टक‍नोलािी‍‍

(डीएतएलटी ‍या‍

तभडलल‍लबोर ी‍

टलनोलाि‍(एतएलटी ‍

या‍बचल ‍आि‍साइस‍

(बीएससी ‍या‍

यो शाला‍भवजञान‍त‍

तास‍ट ‍आि‍साइस‍

(एतएससी ‍या‍

यो शाला‍भवजञान‍त‍

डाक‍ट ‍आि‍िलॉसिी‍

(रीएचडी ‍अहशिा‍‍ल‍

साथ‍यो शाला‍

िलनीदलयो‍ली‍सा‍या

आवश‍यल:‍‍1 आवश‍यल:‍2 आवश‍यल:‍4

सहायल‍लतशचा ीवन‍द‍ि‍

(यो शाला‍सहायल‍

या‍यो शाला,‍

रि च ‍लतशचाि यो‍ल‍

विन‍ला‍ ोस‍ट ,‍र ‍

सतय‍सतय‍र ‍उनला‍

स‍वास‍ ‍य‍िाच‍र ‍

टीलाल ण म‍दलया‍

िाए ा

आवश‍यल:‍1 आवश‍यल:‍1 आवश‍यल:‍2

V उरस‍ल ‍या‍उरल ण म‍या‍रषभिया

(ल ‍भचदलत‍सीय‍

निाभनल‍यो शाला‍ल‍

उरस‍ल ो‍ली‍न‍द‍यनित‍

तारा‍ली‍सची‍

सवा ‍ल‍भवस‍िा ‍ल‍

अनसा ‍आवश‍यल

सवा ‍ल‍भवस‍िा ‍ल‍

अनसा ‍आवश‍यल

सवा ‍ल‍भवस‍िा ‍ल‍अनसा ‍

आवश‍यल

(त ‍भचदलत‍सीय‍

निाभनल‍यो शाला‍ल‍

उरस‍ल ो‍ली‍न‍द‍यनित‍

तारा‍ली‍सची‍

सवा ‍ल‍भवस‍िा ‍ल‍

अनसा ‍आवश‍यल

सवा ‍ल‍भवस‍िा ‍ल‍

अनसा ‍आवश‍यल

सवा ‍ल‍भवस‍िा ‍ल‍अनसा ‍

आवश‍यल

( ‍भवसकरतण म‍ल‍भलए‍

िस‍दल‍हाट‍एय ‍

ऑवन‍र ‍आटोललव‍

आवश‍यल आवश‍यल आवश‍यल

(घ ‍अरभकषि‍

अभगलतशल‍र ‍तरन‍

वाली‍वस‍ि ‍ली‍सची‍

आवश‍यल आवश‍यल आवश‍यल

(ङ ‍त‍याज‍यो‍ली‍सची‍ आवश‍यल आवश‍यल आवश‍यल

(च ‍वारषशल‍अन कषण म‍

सभविा‍या‍व‍यारल‍

अन कषण म‍सभविा‍र ‍

वाछनीय‍ वाछनीय‍ वाछनीय

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8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

उरस‍ल ‍ल‍भलए‍

अभगलत‍(लॉ ‍

रभसिला ‍ली‍रॉभलसी

VI भवभिल‍र ‍लाननी‍अरकषाए

भवभिल‍र ‍लाननी‍

अरकषाए‍िस‍दल‍ ाज‍य‍

या‍सघ‍ ाज‍यकषरो‍ला‍

िवभचदलत‍सा‍अरभश‍‍ट‍

बिन‍अभिभनयत‍ल‍

उरबिो‍ल‍अिीन‍

भिस‍रील ण म,‍‍‍िषण म‍

भनयरण म‍बोडश‍र ‍

स‍थानीय‍उरभवभियो‍ल‍

अनसा ‍रयाशव ण मीय‍

अरकषा ‍ल‍साथ‍

भिस‍रील ण म‍स.‍र ‍

उसल‍अवसान‍ली‍

िा ीत,‍स‍थल,‍ि ह,‍

अवस‍थान।‍

आवश‍यल आवश‍यल आवश‍यल

VII अभगलत‍बनाए‍ तना‍र ‍ि रोटश‍िना

(ल ‍िा ीत‍वा ‍र ‍

भवशषजञिा‍ल‍अनसा ‍

उिाह ण माथश‍ऊिल‍

भवलभि‍भवजञान‍

लोभशला‍भवजञान,‍

भि ‍भवजञान‍र ‍

यो शाला‍ओषभि‍ल‍

अनसा ‍सगी‍ ोभ यो‍

ली‍ि रोट‍‍

आवश‍यल‍(निाभनल‍

स‍थारन‍िी‍ ई‍िानला ी‍

र ‍उरलब‍ि‍आलडो‍लो‍

बनाए‍ त ा

आवश‍यल‍(निाभनल‍

स‍थारन‍िी‍ ई‍िानला ी‍

र ‍उरलब‍ि‍आलडो‍लो‍

बनाए‍ त ा

आवश‍यल‍(निाभनल‍स‍थारन‍िी‍

ई‍िानला ी‍र ‍उरलब‍ि‍

आलडो‍लो‍बनाए‍ त ा

(त ‍भचदलत‍सा‍भवभिल‍

अभगलत‍(भवभि‍ल‍

अनसा ‍यदि‍ला ‍हो‍

आवश‍यल आवश‍यल आवश‍यल

( ‍यो शाला‍त‍

लायश ि‍िलनीदलयो‍ल‍

अभगलत‍लो‍बनाए‍

तना‍भिसत‍उनली‍

अहशिा,‍भशकषण म‍र ‍

अन‍द‍य‍ब‍यौ ‍हो ‍

आवश‍यल आवश‍यल आवश‍यल

(घ ‍भनिश‍रस‍िलालय‍

भिसल‍अन‍द‍ि शि‍रस‍िल ,‍

भनयिलाभलल‍रभरलाए‍

या‍ई-िनशल‍या‍लम‍रल‍‍ट‍

भडस‍ल‍(सीडी ‍उरलब‍ि‍

ल ाई‍िाए ी

वाछनीय वाछनीय वाछनीय

Page 9: स्वास््यर रि वा ल्याण म ...2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] न भनल स थ रन (ल न द रय स ल

II (i) 9

(ङ ‍अभगलतो‍लो‍

बनाए‍ तन‍ली‍अवभि‍

(िो‍सतय‍सतय‍र ‍

ला ‍हो ‍

आवश‍यल आवश‍यल आवश‍यल

VIII बभनयािी‍दकरया ‍ल‍तानल

(ल ‍सकरतण म‍भनयरण म‍

ला‍अनस ण म‍ल ना-‍

िव‍भचदलत‍सा‍अरभश‍‍ट‍

भनयत,‍2016‍ल‍

अनसा ‍

आवश‍यल आवश‍यल आवश‍यल

(त ‍स कषा‍सबिी‍

बाि-‍त‍याज‍य‍सइ ‍ला‍

यो ‍आदि‍

आवश‍यल आवश‍यल आवश‍यल

( ‍ ो ी‍लो‍सचना‍

र ‍िा ल‍(भशभकषि ‍

ल ना‍

आवश‍यल आवश‍यल आवश‍यल

(घ ‍उरस‍ल ो‍र ‍

अभगलतशलो‍ला‍

अशालन‍

आवश‍यल आवश‍यल आवश‍यल

(ङ ‍उरलब‍ि‍सगी‍

दकरया ‍ली‍तानल‍

सचालन‍दकरया‍

रभसिला‍

आवश‍यल आवश‍यल आवश‍यल

(च ‍भशलायि‍ििश‍

ल ना‍र ‍उनलो‍

भनरटान‍ली‍दकरयाभवभि‍

आवश‍यल आवश‍यल आवश‍यल

(छ ‍यथाभसथभि,‍बाह ी‍

ण मिा‍आश‍वासन‍स‍लीत‍

या‍आि ‍यो शाला‍

िलना‍ल‍र‍त‍ ण मिा‍

भनयरण म

वाछनीय वाछनीय वाछनीय

(ि ‍दलए‍ ए‍र ीकषण मो‍

ली‍िकषिा‍र ीकषण म‍ली‍

नीभि‍‍

वाछनीय वाछनीय वाछनीय

[िा.‍स.‍िड.‍28013/40/2017-एत.एस.]

‍लन‍द‍िल‍लाल‍शताश, सयक‍ि‍सभचव

िट‍‍रण म:‍तल‍ भनयत‍ गा ि‍ ल‍ ािरर,‍ असािा ण म,‍ गा ‍ II,‍ तण‍ड‍ 3,‍ उर-तड‍ (i)‍ त‍ िा ीत‍ 23‍ तई,‍ 2012‍ लो‍

सा.ला.भन.‍387(अ ‍ल‍दवा ा‍लाभशि‍दलए‍ ए‍थ‍।

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10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 5th May, 2017

G.S.R. 441(E).—The following draft of certain rules further to amend the Clinical Establishments (Central

Government) Rules, 2012, which the Central Government proposes to make in exercise of the powers conferred by

section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), after consultation with

the National Council for Clinical Establishments, is hereby published for information of all persons likely to be affected

thereby and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a

period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made

available to the public;

Objections and suggestions, if any, may be addressed to the Under Secretary (Medical Services), Ministry of

Health and Family Welfare, Government of India, Room No. 508, D Wing, Nirman Bhavan, New Delhi – 110011 or sent

on email to [email protected];

Objections and suggestions which may be received from any person within the period specified above will be

considered by the Central Government.

DRAFT RULES

1. (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2017.

(2) They shall come into force on the date of their final publication in the Official Gazette.

2. In the Clinical Establishments (Central Government) Rules, 2012, (hereinafter referred to as the said rules),

in rule 2 after clause (b), the following clause shall be inserted, namely.-

‘(bb) “Schedule” means the Schedule appended to these rules’.

3. In the said rules, after rule 8, the following rules shall be inserted, namely:-

“8A. Minimum Standards for diagnosis or treatment of diseases. - Every clinical establishment relating to

diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical,

biological investigations or other diagnostic or investigative services, are usually carried on with the aid of

laboratory or other medical equipment, shall comply with the minimum standards of facilities and services

as specified in the Schedule”.

4. In the said rules, after rule 9, the following Schedule shall be inserted, namely:-

“SCHEDULE

Sl. No. Type of laboratory Basic Composite Medium Advanced

I Definition Laboratories processing

upto 30 samples.

Laboratories processing

between 30 and 100

samples

Laboratories processing more

than 100 samples

II Scope of services These tests can be

performed in mobile

laboratory at field centres

also.

Apart from the tests

performed in basic

composite laboratory,

additional tests

mentioned as under.

Apart from the tests performed

in medium laboratory,

additional tests mentioned as

under.

(a) Biochemistry Routine Biochemistry tests

like Blood Sugar, Renal

Function Tests, Liver

Function Tests, Amylase,

Lipase, Lipid profile,

Cerebro Spinal Fluid

(CSF) and other biological

fluids (glucose and

protein), Oral Glucose

Tolerance Test,

Electrolytes, Calcium or

Phosphate, HbA1c. Any

dry chemistry based rapid

test.

(a) Routine Bio-

chemistry,

(b) Hormone Bioassay,

Tumor markers,

plasma protein

electrophoresis

(a) Routine Biochemistry,

(b) Hormone Bioassay, Tumor

markers, plasma protein

electrophoresis, coagulation

profile, Drug monitoring and

toxicology assay,

(c) Molecular genetics,

Inborn errors of metabolism

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II (i) 11

(b) Haematology Haemogram, Bleeding

Time, Clotting Time,

Prothrombin Time,

Activated Partial

Thromboplastin

Time, Blood grouping

Haemogram, Bleeding

Time, Clotting Time,

Prothrombin Time,

Activated Partial

Thromboplastin Time,

Blood grouping,

Coagulation Assay

All other Haematology tests

also.

(c) Histopathology Not applicable May or may not do

(optional)

Histopathology Examination

(d) Molecular

Genetics

Not applicable May or may not do

(optional)

Molecular genetics

(e) Cytopathology Not applicable PAP smear, Fine

Needle Aspiration

Cytology(FNAC),

sputum and CSF

cytology

PAP smear, FNAC, sputum

cytology and other biological

fluid cytology;

Desirable: Ultrasound and CT

guided FNAC.

(f) Immuno-

histopathology

Not applicable Not applicable Immuno histopathology: As

per scope of laboratory

(g) Medical

Microbiology and

Immunology

Basic tests like Rapid Test

(Point of Care) for

infection, urine routine

examination and

microscopy, Hanging drop

for Vibrio cholerae, Stool

for ova , cyst. all HIV

positive rapid assays need

to be confirmed from the

next level diagnostic

laboratory.

(a) Basic tests as in

basic composite

laboratory.

(b) Serological tests for

viruses, bacteria, fungi,

parasites

(c) Culture sensitivity

tests: Bacterial or

fungal

(d) Other special stains

besides Gram's.

(a) Basic test as in composite

laboratory.

(b) Serological tests for viruses,

bacteria, fungi, parasites.

(c) Culture sensitivity tests,

bacterial or fungal or viruses.

(d) Gene based tests (Nucleic

acid tests for infections like

Real time Polymerase Chain

Reaction (PCR) tests).

Histopathology of infectious

diseases.

Desirable:

Immunocytochemistry

III INFRASTRUCTURE

Basic Composite Medium Advanced

1. Signage

(a) Basic signage- A

signage within or

outside the facility

should be made

available containing

the following

information.

Essential Essential Essential

(b) Name of the

person- in-charge

with qualification

and registration

number

Essential Essential Essential

(c) Broad services

provided, i.e.,

Haematology,

Biochemistry,

Clinical Pathology,

Histology Genetics-

whichever is

applicable

Essential Essential Essential

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12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

(d) Timings of the

different consultants

Essential Essential Essential

(e) Internet facility

or Telephone and

mobile number for

appointment

Desirable Desirable Desirable

(f) Fee structure: To

be displayed

separately including

type of investigation

and charges, i.e.,

Special and routine

tests

Essential Essential Essential

2. Safety Signages (Wherever applicable)

(a) Safety hazard

and caution signs -

Biomedical waste

segregated in

coloured bins and

bags as per

Biomedical waste

Management Rules,

2016 including

radioactive

materials, toxic

chemicals, microbial

agents, infected

biological material.

Essential Essential Essential

(b) Appropriate Fire

exit signages -

Minimum one fire

extinguisher

Desirable Desirable Essential

3. Space requirement

(a) Registration and

waiting room, public

utilities, safe

drinking water etc.

Desirable Essential Essential

(b) Sample

collection area

Essential Essential Essential

(c) Laboratory with

adequate diffuse and

spot lighting

Essential Essential Essential

(d) Toilet Essential Essential Essential

(e) Reporting and

billing area

Essential Essential Essential

(f) Staff room and

doctor's duty room -

Male and female

different where 24

hours services

available

Desirable Desirable Essential

(g)Washing room Essential Essential Essential

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II (i) 13

(h) Preservation of

the specimens and

slides

Essential Essential Essential

(i) Electrical

facilities

Essential Essential Essential

(j) Temperature

control for

specialized

equipment like flow

cytometry and

chemiluminescence

equipment ,

Enzyme-linked

immune sorbent

assay(ELISA) test

equipment etc.

Essential Essential Essential

(k) Counselling

room for HIV

Essential, if HIV test is

done

Essential, if HIV test is

done

Essential, if HIV test is done

(l) FNAC room for

all patients for

sample collection

Desirable Desirable Desirable

(m) Dark room for

tests of Immuno-

fluorescence

Not applicable Not applicable Essential

(n) Frozen Section

facilities

Not applicable Essential as per scope of

services

Essential as per scope of

services

4. Furniture and

fixtures

Essential Essential Essential

5. Communication

system - Telephone

and mobile number

for appointment

Desirable Desirable Desirable

6. Wash Basins Essential Essential Essential

IV HUMAN RESOURCE

(a) Designation,

minimum

qualification of

Technical Head of

Laboratory or

Specialist or

Signatories.

Essential: Bachelor of

Medicine and Bachelor of

Surgery (MBBS )from a

recognised institution

(with at least one year

experience in laboratory

work-Desirable)

Essential: In-charge

may be Doctor of

Medicine (MD) or

Diplomate of National

Board (DNB) in

Pathology or

Biochemistry or

Medical Microbiology

or Laboratory Medicine

or Diploma in Clinical

Pathology (DCP) with

one year post diploma

experience or Bachelor

of Medicine and

Bachelor of Surgery (MBBS) with Doctor of

Philosophy (PhD) in

any of the 3 subjects or

apart from incharge, if

Essential: In-charge can be

Doctor of Medicine (MD) or

Diplomate of National Board

(DNB) Pathology or

Laboratory Medicine or

Biochemistry or Medical

Microbiology or Diploma in

Clinical Pathology (DCP)

with one year post diploma

experience or Bachelor of

Medicine and Bachelor of

Surgery (MBBS) with Doctor

of Philosophy (PhD) in any of

the 3 subjects or apart from in-

charge, if any special test of

other speciality is done, it is

desirable that specialist of that

subject need be there on full

time or part time or outsourced

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14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

any special test of other

speciality is done, it is

desirable that specialist

of that subject needs be

there on full time or part

time or outsourced

(Special tests means any

other apart from routine

basic biochemistry,

haematology, or

medical microbiology

tests as listed in basic

composite laboratory)

(Special tests means any other

apart from routine basic

biochemistry, haematology, or

microbiology tests as listed

above)

(b) Number of

laboratory

technicians with

Diploma in Medical

Laboratory

Technology (DMLT) or Medical

Laboratory

Technology (MLT) or Bachelor of

Science (B.Sc.) in

laboratory sciences

or Master of Science (M.Sc) in laboratory

sciences or Doctor of

Philosophy (Ph.D)

in laboratory

sciences

qualification from

University or

recognized institution.

Essential: 1 Essential: 2 Essential: 4

(c) Support staff

(Laboratory

Assistant or

Laboratory

Attendant) Roster of

salary of staff,

Periodic health

check- ups and vaccination of staff

Essential: 1 Essential: 1 Essential: 2

V INSTRUMENTS OR EQUIPMENT OR DRUGS

(a) List of minimum

medical diagnostics

laboratory

equipment with quantity

Essential as per scope of

services

Essential as per scope

of services

Essential as per scope of

services

(b) List of minimum

medical diagnostics

laboratory

instruments with

quantity

Essential as per scope of

services

Essential as per scope of

services

Essential as per scope of

services

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II (i) 15

(c) Sterilisation such

as hot air oven or

autoclave

Essential Essential Essential

(d) List of reagents

and consumables

required

Essential Essential Essential

(e) List of

disposables

Essential Essential Essential

(f) Policy of annual

maintenance contract

or comprehensive

maintenance contract

and records for

equipment (Log

books)

Desirable Desirable Desirable

VI LEGAL OR STATUTORY REQUIREMENTS

Legal or statutory

requirements such as

registration under

the provisions of the

Biomedical Waste

Management Act

with State or Union

territories’ Pollution

Control Board with

registration number

and date of expiry,

site, space, location

and environmental

requirements to be as

per local bye- laws

Essential Essential Essential

VII RECORD MAINTENANCE AND REPORTING

(a) Reports of all

patients date wise

and specialty wise

for example:

Histopathology,

Cytology,

Haematology and

Laboratory

Medicine.

Essential (Clinical

Establishment to maintain

information and statistics

provided)

Essential (Clinical

Establishment to

maintain information

and statistics provided)

Essential (Clinical

Establishment to maintain

information and statistics

provided)

(b) Medico legal

records, if applicable

Essential Essential Essential

(c) Record keeping

of technicians

working in

laboratory indicating

their details of

qualification training

and others

Essential Essential Essential

(d) Availability of

reference library

including books or

periodicals or

Desirable Desirable Desirable

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16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

[F. No. Z. 28013/40/2017-MS]

K. L. SHARMA, Jt. Secy.

Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide

G.S.R. No. 387(E), dated the 23rd

May, 2012.

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.

e-journals or

Compact

Discs(CDs)

(e) Duration of

preservation of

record (as applicable

from time to time)

Essential Essential Essential

VIII STANDARDS ON BASIC PROCESSES

(a) Infection Control

practices - as per

Bio- Medical Waste

Management Rules ,

2016

Essential Essential Essential

(b) Safety

considerations- use

of disposable

needles etc

Essential Essential Essential

(c) Patient

Information and

Education

Essential Essential Essential

(d) Process of

calibration of

equipment and

reagents

Essential Essential Essential

(e) Booklet of

standard operating

procedures of all

procedures available

Essential Essential Essential

(f) Grievance

registration and

disposal mechanism

Essential Essential Essential

(g) Quality Control

in the form of

external quality

assurance scheme or

inter-laboratory

comparison, as the

case may be

Desirable Desirable Desirable

(h) Policy of

proficiency testing

of tests performed.

Desirable Desirable Desirable”.